Clinical trial · Interventional
Study of JYP0015 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of JYP0015 in Advanced Solid Tumors With RAS Mutation
NCT06895031CI-TRIAL-00104932STARrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluate the safety and antitumor activity of JYP0015 in adults with specific RAS mutant advanced solid tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JYP0015 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JYP0015 in RAS-Mutant Solid Tumors
- description
- This arm includes participants with histologically or pathologically confirmed advanced solid tumors harboring RAS mutations, identified via molecular testing. RAS mutations are defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, 61, 117, or 146 (e.g., G12, G13, Q61, K117, or A146). Participants will receive JYP0015 as an oral tablet.
- interventionNames
- Drug: JYP0015
Primary outcomes (3)
- measure
- Number of Participants with Dose-Limiting Toxicity (DLT)
- timeFrame
- 21 days
- description
- The number of participants experiencing dose-limiting toxicities (DLT) during the dose-escalation period of the study.
- measure
- Incidence and Severity of Treatment-Emergent Adverse Events (AEs) and Serious AEs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or pathologically confirmed solid tumors with RAS mutation via molecular tests. 2. Patients with RAS mutation who have disease progression or intolerance after adequate standard treatment 3. Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1 4. Adequate organ function Exclusion Criteria: 1. Presence of central nervous system (CNS) metastases; however, subjects with previously treated brain metastases may be enrolled if clinically stable. 2. Gastrointestinal (GI) disorders that may interfere with drug administration/absorption, including but not limited to: Dysphagia or inability to swallow tablets, Malabsorption syndrome,Refractory nausea, vomiting, or diarrhea,Chronic GI diseases (e.g., Crohn's disease, ulcerative colitis) 3. Congestive heart failure with New York Heart Association (NYHA) functional class ≥II or left ventricular ejection fraction (LVEF) \<50%. 4. Any other condition deemed by the investigator to potentially compromise study outcomes or lead to premature termination, including but not limited to: Alcohol or substance abuse,Concurrent severe medical conditions (e.g., psychiatric disorders requiring active treatment), Familial or social circumstances that may affect patient safety, compliance, or study data collection.
References
Publications (0)
Data not yet available
No reference posted for this study.